An endoscopic forward negative pressure biopsy needle and biopsy system

Abstract

The application provides an under-mirror forward negative pressure suction rotary cutting biopsy needle and biopsy system, wherein the biopsy needle comprises a distal pipeline part and a proximal handheld part, the proximal handheld part comprises a proximal shell and a rotary cutting knife pipeline transmission assembly, the proximal end of the rotary cutting knife pipeline is installed in the proximal shell through the rotary cutting knife pipeline transmission assembly; a negative pressure interface is arranged on the proximal end wall of the proximal shell; the rotary cutting knife pipeline transmission assembly comprises a circumferential rotation transmission mechanism and an axial movement transmission mechanism, the circumferential rotation transmission mechanism comprises a mandrel assembly and a rotary shaft sleeve which are located in the proximal shell, the mandrel assembly is fixed on the rotary cutting knife pipeline, and the rotary shaft sleeve is sleeved on the mandrel assembly; the rotary shaft sleeve and the rotary cutting knife pipeline are dynamically sealed through a first dynamic sealing element; the proximal end of the rotary shaft sleeve is fixedly and sealingly connected with a rotary joint pipe, the rotary joint pipe is also dynamically sealed with the negative pressure interface through a second dynamic sealing element; the rotary shaft sleeve is driven to rotate, so that the rotary shaft sleeve drives the mandrel assembly to rotate, and then drives the rotary cutting knife pipeline to rotate.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a mirror under positive negative pressure suction rotary cutting biopsy needle and biopsy system BACKGROUND

[0002] Biopsy is a group of medical diagnostic test methods for determining the structure and composition of tissues or cells. In biopsy, a sample of cells or tissue is taken from an organ or other body part, and after being sent to the pathology department, standard pathological sections are made, and the morphological structure changes are observed under a microscope, and finally a clear pathological diagnosis can be given to guide targeted treatment. Generally, if an abnormality is found through superficial examination, such as palpation or radiographic imaging, a biopsy can be performed to determine the nature of the suspected abnormality.

[0003] Endoscopic ultrasound-guided transbronchial needle aspiration biopsy is a minimally invasive examination technique for puncture biopsy of lung, peripulmonary tissue and lymph node under real-time ultrasound guidance. Its advantages are that it can avoid important parts such as large blood vessels and nerves as much as possible under real-time ultrasound monitoring, reduce the risk of massive bleeding, improve the accuracy of sampling, and is minimally invasive, simple to operate and relatively safe.

[0004] Traditional endoscopic ultrasound biopsy needles need to be repeatedly punctured for sampling, and the integrity of the sampled tissue is poor, thus causing low sampling efficiency and poor sample quality.

[0005] Rotary cutting biopsy needles differ from traditional biopsy needles in that they have a rotary cutting knife tube that is rotated by a motor, replacing the traditional reciprocating puncture sampling with rotary cutting to improve sampling efficiency and sample quality.

[0006] However, due to its structure, the rotary cutting biopsy needle cannot achieve the sealing of the rotary cutting knife tube while meeting the normal rotation and forward and backward movement of the rotary cutting knife tube, and thus cannot achieve negative pressure suction of the rotary cutting knife tube. SUMMARY

[0007] To solve the above technical problems, an embodiment of the present application provides a mirror under positive negative pressure suction rotary cutting biopsy needle, which comprises a distal end pipeline part and a proximal end handheld part, the distal end pipeline part comprises an outer sheath tube, a rotary cutting knife tube and a puncture needle which are successively movably sleeved from outside to inside, and the proximal end handheld part comprises a proximal end shell and a rotary cutting knife tube transmission assembly, the proximal end of the rotary cutting knife tube is installed in the proximal end shell through the rotary cutting knife tube transmission assembly.

[0008] A negative pressure interface is formed on the proximal end wall of the proximal end shell, and the negative pressure interface is used to connect a negative pressure device.

[0009] The rotation cutting knife tube transmission assembly comprises a circumferential rotation transmission mechanism and an axial movement transmission mechanism. The circumferential rotation transmission mechanism comprises a mandrel assembly and a rotation sleeve, the mandrel assembly is fixedly sleeved on the rotation cutting knife tube, the rotation sleeve is sleeved on the mandrel assembly and is axially slidably connected with the mandrel assembly and circumferentially fixedly connected with the mandrel assembly; the rotation sleeve and the rotation cutting knife tube are dynamically sealed by a first dynamic sealing element; the proximal end of the rotation sleeve is fixedly and sealingly communicated with a screw joint, and the screw joint is dynamically sealed with the negative pressure interface by a second dynamic sealing element; the rotation sleeve is driven to rotate, so that the rotation sleeve drives the mandrel assembly to rotate, and then drives the rotation cutting knife tube to rotate.

[0010] The axial movement transmission mechanism comprises a screw sleeve and a transmission screw, the screw sleeve is rotationally arranged in the proximal end shell and is in threaded engagement with the transmission screw; the transmission screw is sleeved on the rotation sleeve and is axially fixedly connected with the mandrel assembly and circumferentially rotationally connected with the mandrel assembly; the screw sleeve is driven to rotate, so that the rotation movement of the screw sleeve is converted into the axial movement of the transmission screw, and then the transmission screw drives the mandrel assembly and the rotation cutting knife tube to move axially.

[0011] Optionally, a rotation gear is fixedly connected to the rotation sleeve, and the rotation sleeve drives the rotation gear to rotate by a rotation driving motor.

[0012] Optionally, a stroke gear is fixedly connected to the screw sleeve, and the screw sleeve drives the stroke gear to rotate by a stroke driving motor.

[0013] Optionally, the proximal end hand-held part further comprises a motor handle, the rotation driving motor and the stroke driving motor are both mounted in the motor handle, and the motor handle is fixedly connected with the proximal end shell.

[0014] Optionally, the mandrel assembly comprises a fixed tube and an inner knife sleeve, the fixed tube is fixedly sleeved on the rotation cutting knife tube, the inner knife sleeve is fixedly sleeved on the fixed tube, the rotation sleeve is sleeved on the inner knife sleeve, and the rotation sleeve and the inner knife sleeve are axially slidably connected and circumferentially fixedly connected by inserting an axial protrusion into an axial guide groove.

[0015] The inner knife sleeve and the transmission screw are circumferentially rotationally connected and axially fixedly connected by inserting an annular limiting clamping element provided on the inner knife sleeve into an annular limiting clamping groove.

[0016] Optionally, a guide rail is further provided on the inner wall of the proximal end shell, and the transmission screw is slidably arranged on the guide rail.

[0017] Optionally, the proximal handheld part further comprises an endoscope fixing member and a distal shell, the endoscope fixing member comprises a sheath seat and a sheath seat locking member, the sheath seat movably sheaths the outer sheath tube; the sheath seat is provided with a second luer fitting which is adapted to a first luer fitting on the endoscope, the sheath seat is assembled and connected with the endoscope through the assembly of the first luer fitting and the second luer fitting, so as to realize the fixed connection with the endoscope.

[0018] The distal shell fixedly sheaths the proximal end of the outer sheath tube, the sheath seat is axially slidably connected with the distal end of the distal shell, and the sheath seat locking member can lock the distal shell; the proximal end of the distal shell is axially slidably connected with the distal end of the proximal shell.

[0019] Optionally, the proximal handheld part further comprises a puncture depth adjusting device, the puncture depth adjusting device comprises an adjusting sleeve and a sleeve locking member, in use, the puncture depth is set by adjusting the position of the adjusting sleeve on the distal shell first; then the adjusting sleeve is locked on the distal shell through the sleeve locking member; finally, the proximal shell is slid distally to realize puncture.

[0020] Optionally, the distal shell is provided with a scale of puncture depth.

[0021] Optionally, the inner ring of the rotating shaft sleeve is provided with a first groove, and the first dynamic sealing member is fixedly installed in the first groove.

[0022] Optionally, the inner side of the proximal end wall of the proximal shell is provided with a second groove, the second groove is in communication with the negative pressure interface, and the second dynamic sealing member is fixedly installed in the second groove.

[0023] Optionally, the first dynamic sealing member or / and the second dynamic sealing member is a sealing ring.

[0024] Optionally, the sealing ring is a generic sealing ring or a silica gel sealing ring.

[0025] Optionally, the rotary cutting knife tube comprises a distal end metal tube, a metal wire spring tube, a proximal end metal tube and a high polymer sealing tube, the distal end of the distal end metal tube is an annular blade, the proximal end surface of the distal end metal tube is fixedly connected with the distal end surface of the metal wire spring tube; the high polymer sealing tube at least sheaths the metal wire spring tube and the connection between the metal wire spring tube and the distal end metal tube; the proximal end metal tube is fixedly sheathed on the proximal end of the high polymer sealing tube.

[0026] Another embodiment of the present application also provides a below-the-scope positive-negative pressure suction biopsy system, comprising the biopsy needle and the negative pressure device in the above-mentioned embodiments, and the negative pressure device performs negative pressure suction on the tissue in the coring cutter tube through the negative pressure interface.

[0027] Optionally, the biopsy system further comprises a syringe, which injects physiological saline into the coring cutter tube through the negative pressure interface after sampling is completed, so as to flush the tissue sample in the coring cutter tube out.

[0028] Optionally, the biopsy system further comprises a host computer, and the host computer comprises a master control module, which is electrically connected with the negative pressure device through the negative pressure driving module and controls the negative pressure size of the negative pressure device.

[0029] Compared with the prior art, the technical scheme of the embodiment of the present application has the following beneficial effects:

[0030] Since the coring cutter tube rotates and moves axially relative to the proximal end shell, the present application decomposes the sealing of the coring cutter tube into axial sealing and rotary sealing. The specific implementation scheme of the axial sealing is that, in the rotary shaft sleeve, the rotary shaft sleeve and the coring cutter tube are dynamically sealed through the first dynamic sealing element (since the axial movement speed of the coring cutter tube is relatively slow, the relative speed of the coring cutter tube and the first dynamic sealing element is small, the wear requirement of the first dynamic sealing element is low, which is conducive to the miniaturization of the first dynamic sealing element, so that the first dynamic sealing element can be placed in the narrow space in the rotary shaft sleeve); the proximal end of the rotary shaft sleeve is fixedly sealed in communication with a rotary joint pipe. During sampling, no matter how the coring cutter tube moves axially, the proximal end port of the coring cutter tube is always located in the space between the distal end port of the rotary joint pipe in the rotary shaft sleeve and the first dynamic sealing element. Therefore, a sealed space is formed between the proximal end of the rotary shaft sleeve and the first dynamic sealing element to accommodate the axial movement of the coring cutter tube. The specific implementation scheme of the rotary sealing is that, during sampling, since the rotary joint pipe rotates synchronously with the rotary shaft sleeve, relative rotation occurs between the rotary joint pipe and the negative pressure interface. Based on this, the present application dynamically seals the relative rotation between the rotary joint pipe and the negative pressure interface, that is, the rotary joint pipe is dynamically sealed in communication with the negative pressure interface through the second dynamic sealing element, so as to realize the rotary sealing of the coring cutter tube. Thus, the present application solves the sealing problem of the coring cutter tube, and further realizes the negative pressure suction of the coring biopsy needle.

[0031] Further, in the present application, the negative pressure suction can improve the sampling amount of the coring cutter tube. During sampling, as the tissue in the inner cavity of the coring cutter tube increases, the friction between the tissue and the coring cutter tube will continuously increase, and the frictional resistance will affect the sample tissue to enter the deep part of the inner cavity of the coring cutter tube, so that the obtained sample tissue cannot be increased. However, the suction force provided by the negative pressure can overcome the frictional resistance and suck more sample tissue into the inner cavity of the coring cutter, so as to improve the sampling amount.

[0032] Further, the application can gradually increase the negative pressure value as the rotating cutter tube advances during the sampling process through the host's fine control of the negative pressure, thereby avoiding excessive negative pressure in the early stage that damages the integrity of the tissue sample.

[0033] Further, in the application, since the rotating cutter tube is a tubular structure with a ring-shaped blade at the distal end, the tissue at the cutting edge needs to be pulled off after sampling is completed. For some tissue structures that are difficult to pull off, the pulling force may be insufficient, leading to sampling failure. Negative pressure suction can increase the pulling force of the rotating cutter tube when it is retracted, ensuring that the tissue can be successfully pulled off.

[0034] Further, in the application, after sampling is completed, physiological saline is injected into the rotating cutter tube through the negative pressure interface to provide positive pressure, which pushes the tissue sample out of the rotating cutter tube, avoiding damage to the sample caused by the rigid needle.

[0035] Of course, implementing any product of the application does not necessarily require all the advantages described above. BRIEF DESCRIPTION OF DRAWINGS

[0036] In order to more clearly illustrate the technical solutions in the embodiments of the application or the prior art, the following will briefly introduce the drawings needed to be used in the embodiments or prior art description. Obviously, the drawings in the following description only constitute some embodiments of the application, and for those skilled in the art, other drawings can also be obtained without creative labor.

[0037] Figure 1 is a structural schematic diagram of a negative pressure suction rotating biopsy needle provided by an embodiment of the application (with a motor handle installed);

[0038] Figure 2 is a structural schematic diagram of the distal end pipeline part provided by an embodiment of the application;

[0039] Figure 3 is a structural schematic diagram of a rotating cutter tube provided by an embodiment of the application;

[0040] Figure 4 is a structural schematic diagram of a rotating cutter tube with an inner blade cutting edge provided by an embodiment of the application;

[0041] Figure 5 is a structural schematic diagram of a rotating cutter tube with an outer blade cutting edge provided by an embodiment of the application;

[0042] Figure 6 is a structural schematic diagram of a negative pressure suction rotating biopsy needle provided by an embodiment of the application (without a motor handle installed);

[0043] Figure 7 is a sectional view of a negative pressure suction rotary biopsy needle provided by an embodiment of the present application;

[0044] Figure 8 is a structural schematic view of the structure in the distal end shell of the negative pressure suction rotary biopsy needle provided by an embodiment of the present application;

[0045] Figure 9 is a structural schematic view of the rotary cutter tube moving to the farthest end in the axial direction provided by an embodiment of the present application;

[0046] Figure 10 is a structural schematic view of the rotary cutter tube moving to the nearest end in the axial direction provided by an embodiment of the present application. DETAILED DESCRIPTION

[0047] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only some of the embodiments of the present application, but not all the embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative work fall within the scope of protection of the present application.

[0048] The terms "first", "second", "third", "fourth" and the like (if any) in the description, claims and above drawings of the present application are used to distinguish similar objects, and do not necessarily indicate a specific order or sequence. It should be understood that the data thus used can be interchanged under appropriate circumstances, so that the embodiments of the present application described herein can be implemented in an order other than that illustrated or described herein. In addition, the terms "include" and "have" and any variations thereof are intended to cover non-exclusive inclusion, for example, a process, method, system, product or device including a series of steps or units does not necessarily have to be limited to those steps or units clearly listed, but can include other steps or units not clearly listed or inherent to the process, method, product or device. The terms "on" and "above" and any variations thereof are intended to describe the positional relationship, and do not represent a direct contact relationship between the described objects.

[0049] As described in the background, the existing rotary biopsy needle cannot realize the sealing of the rotary cutter tube on the basis of meeting the normal rotation and forward and backward movement of the rotary cutter tube due to its structure, and thus cannot realize the negative pressure suction of the rotary cutter tube.

[0050] To solve the above technical problems, the application provides a mirror-down positive-negative pressure suction rotary cutting biopsy needle, which comprises a distal pipeline part and a proximal handheld part, the distal pipeline part comprises, from outside to inside, an outer sheath tube, a rotary cutting knife tube and a puncture needle which are arranged in sequence; the proximal handheld part comprises a proximal shell and a rotary cutting knife tube transmission assembly, the proximal end of the rotary cutting knife tube is installed in the proximal shell through the rotary cutting knife tube transmission assembly;

[0051] A negative pressure interface is arranged on the proximal end wall of the proximal shell, and the negative pressure interface is used for connecting a negative pressure device;

[0052] The rotary cutting knife tube transmission assembly comprises a circumferential rotation transmission mechanism and an axial movement transmission mechanism, the circumferential rotation transmission mechanism comprises a mandrel assembly and a rotary shaft sleeve which are located in the proximal shell, the mandrel assembly is fixedly sleeved on the rotary cutting knife tube, the rotary shaft sleeve is sleeved on the mandrel assembly and is in axial sliding connection and circumferential relative fixed connection with the mandrel assembly; the rotary shaft sleeve and the rotary cutting knife tube are dynamically sealed through a first dynamic sealing element; the proximal end of the rotary shaft sleeve is fixedly and sealingly connected with a rotary joint pipe, the rotary joint pipe is also dynamically sealed with the negative pressure interface through a second dynamic sealing element; the rotary shaft sleeve is driven to rotate, so that the rotary shaft sleeve drives the mandrel assembly to rotate, and then drives the rotary cutting knife tube to rotate;

[0053] The axial movement transmission mechanism comprises a screw sleeve and a transmission screw, the screw sleeve is rotationally arranged in the proximal shell and is in threaded engagement transmission with the transmission screw; the transmission screw is sleeved on the rotary shaft sleeve and is in axial relative fixation and circumferential relative rotation connection with the mandrel assembly; the screw sleeve is driven to rotate, so that the rotary motion of the screw sleeve is converted into the axial movement of the transmission screw, and then the transmission screw drives the mandrel assembly and the rotary cutting knife tube to move axially.

[0054] Since the rotary cutter tube is in rotational movement and axial movement relative to the proximal end shell, the present application decomposes the sealing of the rotary cutter tube into axial sealing and rotational sealing, the specific implementation scheme of the axial sealing is that: in the rotary shaft sleeve, the rotary shaft sleeve and the rotary cutter tube are dynamically sealed by the first dynamic sealing element (since the axial movement speed of the rotary cutter tube is slow, the relative speed of the rotary cutter tube and the first dynamic sealing element is small, the wear requirement of the first dynamic sealing element is low, which is conducive to the miniaturization of the first dynamic sealing element, so that the first dynamic sealing element can be placed in the narrow space in the rotary shaft sleeve); the proximal end fixed sealing of the rotary shaft sleeve is communicated with a rotary joint pipe, no matter how the rotary cutter tube moves axially, the proximal end port of the rotary cutter tube is always located in the space between the distal end port of the rotary joint pipe in the rotary shaft sleeve and the first dynamic sealing element, so that a sealed space is formed between the proximal end of the rotary shaft sleeve and the first dynamic sealing element to accommodate the axial movement of the rotary cutter tube. The specific implementation scheme of the rotational sealing is that: during sampling, since the rotary joint pipe is synchronous with the rotary shaft sleeve, relative rotation will occur between the rotary joint pipe and the negative pressure interface, based on this, the present application dynamically seals the relative rotation between the rotary joint pipe and the negative pressure interface, that is, the rotary joint pipe is dynamically sealed and communicated with the negative pressure interface by the second dynamic sealing element, so as to realize the rotational sealing of the rotary cutter tube. Thus, the present application solves the sealing problem of the rotary cutter tube, and further realizes the negative pressure suction of the rotary biopsy needle.

[0055] Moreover, the negative pressure suction can improve the sampling amount of the rotary cutter tube. During sampling, as the tissue in the inner cavity of the rotary cutter tube increases, the friction between the tissue and the rotary cutter tube will increase, and the friction resistance will affect the sample tissue to enter the deep part of the inner cavity of the rotary cutter tube, so that the obtained sample tissue cannot be increased. The suction force provided by the negative pressure can overcome the friction resistance and suck more sample tissue into the inner cavity of the rotary cutter, thereby improving the sampling amount.

[0056] Meanwhile, through the fine control of the host to the negative pressure, the negative pressure value can be gradually increased during the sampling process as the rotary cutter tube continuously advances, so as to avoid that the negative pressure value is too high in the early stage and damages the integrity of the tissue sample.

[0057] Since the rotary cutter tube is a tubular structure, the distal end thereof is a ring-shaped blade, and after sampling is completed, the tissue at the blade edge needs to be pulled off to complete sampling. For some tissue structures that are difficult to pull off, the pulling force may be insufficient, resulting in sampling failure. The negative pressure suction can increase the pulling force of the rotary cutter tube when it retreats, so as to ensure that the tissue can be successfully pulled off.

[0058] After sampling is completed, physiological saline is injected into the rotary cutter tube through the negative pressure interface, and the tissue sample is flushed out of the rotary cutter tube by injecting the physiological saline to provide positive pressure, so as to avoid the damage of the sample caused by the ejection of the rigid needle.

[0059] In order to make the above-mentioned purposes, features and benefits of the present application more obvious and easy to understand, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the present application.

[0060] Embodiment 1

[0061] Please refer to Figures 1 to 10 , an embodiment of the present application provides a below-scope positive-negative pressure suction and rotary cutting biopsy needle, comprising a distal pipeline part 1 and a proximal hand-held part 2, the distal pipeline part 1 comprises an outer sheath tube 101, a rotary cutting knife tube 102 and a puncture needle 103 which are successively sleeved from outside to inside.

[0062] The outer sheath tube 101 is the outermost layer of the distal pipeline part 1 of the biopsy needle, and its inner cavity can completely accommodate the rotary cutting knife tube 102 and the puncture needle 103, so that the puncture needle 103 or the rotary cutting knife tube 102 is prevented from damaging the endoscope during the process of conveying the outer sheath tube 101 into the working channel of the endoscope.

[0063] The material of the outer sheath tube 101 is not limited in the present application, and preferably smooth polymer materials such as PTFE and PEEK are used to prevent the endoscope from being damaged during the process of passing through the working channel of the endoscope and to ensure the conveying performance.

[0064] The single-side wall thickness of the outer sheath tube 101 is not limited in the present application and can be set according to actual use requirements. As an embodiment, the single-side wall thickness of the outer sheath tube 101 is greater than 0.15 mm to ensure that it has sufficient strength to support the rotary cutting knife tube 102, so that the rotary cutting knife tube 102 can rotate at high speed inside.

[0065] The rotary cutting knife tube 102 is a tubular structure and is used to collect tissue samples as an intermediate layer of the distal pipeline part 1 of the biopsy needle. The distal end of the rotary cutting knife tube 102 is provided with a ring-shaped blade to ensure that the rotary cutting knife tube 102 can smoothly cut open the tissue. The ring-shaped blade preferably adopts a flat mouth structure to ensure the integrity of the tissue after rotary cutting and prevent the tissue from being mashed to affect pathological analysis.

[0066] As an embodiment, please refer to Figure 4 , the ring-shaped blade at the distal end of the rotary cutting knife tube 102 is an inner blade edge 1021 formed by removing the outer corners of the distal end face of the rotary cutting knife tube 102, and the inner blade edge 1021 is used for cutting high-density tissue.

[0067] As another embodiment, please refer to Figure 5The annular blade at the distal end of the rotary cutter tube 102 is an outer blade edge 1021' formed by removing the inner corner of the distal end face of the rotary cutter tube 102, which is used for cutting low-density tissues.

[0068] In a specific embodiment, please refer to Figure 3 The rotary cutter tube 102 includes a distal metal tube 1022, a metal wire spring tube 1023, a proximal metal tube 1025, and a polymer sealing tube 1024. The distal metal tube 1022 and the proximal metal tube 1025 are both metal tubes, such as stainless steel tubes. The distal end of the distal metal tube 1022 is an annular blade 1021. The distal metal tube 1022 is made of metal to ensure that the rotary cutter tube 102 can smoothly cut tissues. The proximal metal tube 1025 is also made of metal to facilitate its assembly and fixation. The metal wire spring tube 1023 is a hollow tube woven by metal wires, such as stainless steel or nickel-titanium structures. In a bent state, the metal wire spring tube 1023 can flexibly transmit rotary speed and torque and effectively reduce vibration. The proximal end of the distal metal tube 1022 is connected to the distal end of the metal wire spring tube 1023 by end face welding to ensure that the outer diameter and the inner diameter of the distal metal tube 1022 and the metal wire spring tube 1023 are substantially consistent.

[0069] On the outside of the rotary cutter tube 102, there is a thin-walled polymer sealing tube 1024. The outer surface of the rotary cutter tube 102 is covered with the polymer sealing tube 1024, which at least seals the metal wire spring tube 1023 and the connection between the metal wire spring tube 1023 and the distal metal tube 1022. For example, a thin-walled heat shrink tube can be used to fix the outside of the rotary cutter tube 102 through a heat shrink process to seal the rotary cutter tube 102, allowing the internal cavity to transmit negative pressure or positive pressure and avoiding leakage at the welding position, gaps between the woven tubes, etc. At the same time, the thin-walled heat shrink tube can reduce the friction between the rotary cutter tube 102 and the puncture needle 103 when rotating and avoid wear of the woven metal wires of the rotary cutter tube 102.

[0070] The proximal metal tube 1025 is wrapped on the outside of the proximal end of the polymer sealing tube 1024 and can be fixed to the polymer sealing tube 1024 by adhesion or other means. In this way, a sealed tube cavity with only two outlets can be formed inside the rotary cutter tube 102. Moreover, the proximal metal tube 1025 is always in dynamic sealing connection with the first dynamic sealing member 208.

[0071] As an example, the metal wire spring tube 1023, the polymer sealing tube 1024, and the proximal metal tube 1025 are flush at the proximal end face.

[0072] In order to increase the adhesion strength of the tissue after cutting and prevent the tissue from falling off after cutting and sampling, the inner wall surface of the rotary cutting blade tube 102 is provided with a rough surface that increases the friction coefficient, such as a threaded surface.

[0073] In order to improve the effect of ultrasonic imaging, an ultrasonic reflection area is provided on the outer surface of the distal metal tube 1022. The ultrasonic reflection area is required to have an uneven texture. As for the texture shape of the ultrasonic reflection area, the present invention does not impose any specific restrictions. For example, the roughness of the outer surface of the distal metal tube 1022 can be increased by processes such as threading and dotting to improve the imaging effect of the rotary cutting tube 102 under ultrasound.

[0074] During sampling, the rotary cutter tube 102 can rotate and advance axially, cutting tissue while storing the cut tissue in the inner cavity of the annular blade. After cutting, the rotary cutter tube 102 moves axially backward, and the negative pressure and friction force are used to break the tissue, completing the sampling.

[0075] The puncture needle 103, which serves as the innermost layer of the distal tubing section 1 of the biopsy needle, can be a nickel-titanium needle. Its sharp tip helps the rotary cutter tube 102 puncture and penetrate the tissue wall to reach the designated sampling location. The annular blade at the distal end of the rotary cutter tube 102 is an inner blade edge 1021 formed by removing the outer corners from the distal end face of the rotary cutter tube 102, allowing for easy penetration of the tracheal wall. After penetration, the puncture needle 103 is withdrawn from the rotary cutter tube 102, freeing up space for the transfer of negative pressure.

[0076] The proximal handheld portion 2 includes a proximal housing 204 and a rotary cutter tube transmission assembly. The proximal end of the rotary cutter tube 102 is installed in the proximal housing 204 through the rotary cutter tube transmission assembly.

[0077] A negative pressure interface 2041 is provided on the proximal end wall of the proximal housing 204. The negative pressure interface 2041 is used to connect a negative pressure device. The present invention does not limit the specific type of the negative pressure device, which can be a negative pressure suction syringe or a negative pressure pump.

[0078] The rotary cutter tube transmission assembly is installed in the proximal housing 204 , and the rotary cutter tube transmission assembly is connected to the rotary cutter tube 102 . The rotary cutter tube 102 is driven by the rotary cutter tube transmission assembly to perform rotary cutting on the tissue.

[0079] The rotation cutting knife tube transmission assembly can drive the rotation cutting knife tube 102 to rotate to cut tissues, and can also adjust the axial stroke of the rotation cutting knife tube 102 to adjust the cutting depth of the rotation cutting knife tube 102. Therefore, the rotation cutting knife tube transmission assembly comprises a circumferential rotation transmission mechanism and an axial movement transmission mechanism, both of which are connected with the rotation cutting knife tube 102. The circumferential rotation transmission mechanism drives the rotation cutting knife tube 102 to rotate to cut tissues, and the axial movement transmission mechanism drives the rotation cutting knife tube 102 to move axially to adjust the axial stroke of the rotation cutting knife tube 102, thereby adjusting the cutting depth of the rotation cutting knife tube 102.

[0080] Please refer to Figure 8 The circumferential rotation transmission mechanism comprises a mandrel assembly 209 and a rotation sleeve 207 in the proximal end shell 204. The mandrel assembly 209 is fixedly sleeved on the rotation cutting knife tube 102, and the rotation sleeve 207 is sleeved on the mandrel assembly 209 and axially slidably connected with the mandrel assembly 209 while being circumferentially fixedly connected with the mandrel assembly 209. The rotation sleeve 207 is driven to rotate, so that the rotation sleeve 207 drives the mandrel assembly 209 to rotate, and in turn drives the rotation cutting knife tube 102 to rotate. The driving device for driving the rotation sleeve 207 to rotate is not limited in the application, and can be pneumatic, hydraulic or electric. As an embodiment, the driving device adopts a rotation driving motor. Specifically, a rotation gear 214 is coaxially and fixedly connected with the rotation sleeve 207, and the rotation gear 214 is driven by the rotation driving motor, so that the rotation sleeve 207 drives the mandrel assembly 209 to rotate.

[0081] The rotation sleeve 207 and the mandrel assembly 209 are axially slidably connected and circumferentially fixedly connected by sleeving each other, which is a mature technical means in the mechanical field. Therefore, the specific connection structure of the rotation sleeve 207 and the mandrel assembly 209 is not limited in the application.

[0082] As an embodiment, the mandrel assembly 209 comprises a fixed tube and an inner knife sleeve. The fixed tube is fixedly sleeved on the rotation cutting knife tube 102, and the inner knife sleeve is fixedly sleeved on the fixed tube. The rotation sleeve 207 is sleeved on the inner knife sleeve, and the rotation sleeve 207 and the inner knife sleeve are axially slidably connected and circumferentially fixedly connected by the protrusions in the axial direction being inserted into the guide grooves in the axial direction.

[0083] In a specific implementation, the inner wall of the rotating sleeve 207 is provided with a plurality of protrusions which are arranged along the circumferential direction and the axial direction of the rotating sleeve 207; the outer wall of the inner cutter sleeve is provided with a plurality of guide grooves which are arranged along the circumferential direction and the axial direction of the inner cutter sleeve and are adapted to the protrusions. The protrusions are inserted into the guide grooves to achieve the axial sliding connection and the circumferential fixed connection between the rotating sleeve 207 and the inner cutter sleeve, i.e., the rotating sleeve 207 and the inner cutter sleeve can axially slide relative to each other and synchronously rotate in the circumferential direction. Of course, the protrusions can also be arranged on the outer wall of the inner cutter sleeve and the guide grooves can be arranged on the inner wall of the rotating sleeve 207. This embodiment does not make specific limitations in this regard.

[0084] In the present application, the rotating sleeve 207 and the rotary cutter tube 102 are dynamically sealed by the first dynamic seal 208; the proximal end of the rotating sleeve 207 is fixedly sealed to a rotary joint pipe 215 which is dynamically sealed to the negative pressure interface 2041 by the second dynamic seal 206.

[0085] Since the rotary cutter tube 102 rotates and moves axially relative to the proximal end shell 204, the sealing of the rotary cutter tube 102 is decomposed into axial sealing and rotary sealing in the present application.

[0086] The specific implementation of the axial sealing is as follows: in the rotating sleeve 207, the rotating sleeve 207 and the rotary cutter tube 102 are dynamically sealed by the first dynamic seal 208; the proximal end of the rotating sleeve 207 is fixedly sealed to the rotary joint pipe 215, and during sampling, no matter how the rotary cutter tube 102 moves axially, the distal end port of the rotary cutter tube 102 is always located in the space 212 between the distal end port of the rotary joint pipe 215 in the rotating sleeve 207 and the first dynamic seal 208, so that a sealed space 212 is formed between the proximal end of the rotating sleeve 207 and the first dynamic seal 208 to accommodate the axial movement of the rotary cutter tube 102. Please refer to Figure 9 During sampling, the rotary cutter tube 102 rotates and moves axially forward, and when the rotary cutter tube 102 moves axially to the farthest end, the rotary cutter tube 102 is still dynamically sealed to the rotating sleeve 207 by the first dynamic seal 208, and the distal end port of the rotary cutter tube 102 is still located in the space 212' between the rotary joint pipe 215 in the rotating sleeve 207 and the first dynamic seal 208. Please refer to Figure 10 After cutting is completed, the rotary cutter tube 102 moves axially backward, and when the rotary cutter tube 102 moves axially to the farthest end, the rotary cutter tube 102 is still dynamically sealed to the rotating sleeve 207 by the first dynamic seal 208, and the distal end port of the rotary cutter tube 102 is still located in the space 212'' between the rotary joint pipe 215 in the rotating sleeve 207 and the first dynamic seal 208.

[0087] The specific implementation of the rotating seal is that, when sampling, the rotating sleeve 215 rotates synchronously with the rotating shaft sleeve 207, and relative rotation occurs between the rotating sleeve 215 and the negative pressure interface 2041. Based on this, the application performs dynamic sealing on the relative rotation between the rotating sleeve 215 and the negative pressure interface 2041, that is, the rotating sleeve 215 is in dynamic sealing communication with the negative pressure interface 2041 through the second dynamic sealing element 206, and the rotating seal of the rotating cutter tube 102 is realized.

[0088] In order to facilitate assembly and fixation, the rotating sleeve 215 is a metal pipe, such as a steel pipe. The rotating sleeve 215 and the second dynamic sealing element 206 constitute a rotating seal, and no leakage occurs at a high rotating speed (> 3000 RPM). The rotating sleeve 215 has a surface roughness requirement, and generally Ra < 0.2.

[0089] Since the dynamic sealing element is a relatively mature technology in the field of mechanical fluid transmission, the specific structure of the first dynamic sealing element 208 and the second dynamic sealing element 206 is not limited.

[0090] As an embodiment, the first dynamic sealing element 208 and the second dynamic sealing element 206 are sealing rings, such as generic sealing rings or silica gel sealing rings.

[0091] The inner ring of the rotating shaft sleeve 207 is provided with a first groove, and the first dynamic sealing element 208 is fixedly installed in the first groove. The inner surface of the first dynamic sealing element 208 and the outer surface of the rotating cutter tube 102 should be as smooth as possible to reduce the friction resistance caused by sealing.

[0092] The inner side of the proximal end wall of the proximal end shell 204 is provided with a second groove, the second groove is in communication with the negative pressure interface 2041, and the second dynamic sealing element 206 is fixedly installed in the second groove. The inner surface of the second dynamic sealing element 206 and the outer surface of the rotating sleeve 215 should be as smooth as possible to reduce the friction resistance caused by sealing.

[0093] As an embodiment, the negative pressure interface 2041 is provided with a luer joint, and the luer joint can be connected to a negative pressure suction needle cylinder or a negative pressure pump structure.

[0094] The axial movement transmission mechanism comprises a screw sleeve 210 and a transmission screw 211, the screw sleeve 210 is rotationally arranged in the proximal end shell 204 and is in threaded engagement with the transmission screw 211; the transmission screw 211 is sleeved on the rotating shaft sleeve 207 and is axially fixedly connected with the mandrel assembly 209 and is circumferentially rotationally connected with the mandrel assembly 209; the rotation of the screw sleeve 210 is driven, so that the rotational movement of the screw sleeve 210 is converted into the axial movement of the transmission screw 211, and then the transmission screw 211 drives the axial movement of the mandrel assembly 209 and the rotary cutter tube 102. The driving device for driving the rotation of the screw sleeve 210 is not limited in the application and can be pneumatic, hydraulic or electric. As an embodiment, the driving device adopts a stroke driving motor, specifically, the screw sleeve 210 is coaxially and fixedly connected with a stroke gear 213, the stroke gear 213 is driven to rotate by a stroke driving motor, the rotation of the stroke gear 213 drives the rotation of the screw sleeve 210, and the rotational movement of the screw sleeve 210 is converted into the axial movement of the transmission screw 211. The transmission screw 211 is sleeved on the rotating shaft sleeve 207 and is axially fixedly connected with the mandrel assembly 209 and is circumferentially rotationally connected with the mandrel assembly 209.

[0095] As an embodiment, the proximal end handheld part 2 further comprises a motor handle 205, the rotation driving motor and the stroke driving motor are both mounted in the motor handle 205, and the motor handle 205 is fixedly connected with the proximal end shell 204. The rotation driving motor and the stroke driving motor directly control or control the rotary cutter gear and the stroke gear 213 through gear transmission, respectively, so as to realize the rotation and forward and backward movement of the rotary cutter tube 102.

[0096] The screw sleeve 210 only rotates in the proximal end shell 204 and does not axially move. In order to limit the axial movement of the screw sleeve 210 in the proximal end shell 204, positioning partition plates are arranged on the proximal end and the distal end of the screw sleeve 210 and on the proximal end shell 204, so as to limit the screw sleeve 210 between the two positioning partition plates and prevent the axial movement of the screw sleeve 210.

[0097] In the embodiment, the transmission screw 211 is sleeved on the rotating shaft sleeve 207 and is axially fixedly connected with the mandrel assembly 209 and is circumferentially rotationally connected with the mandrel assembly 209.

[0098] As an embodiment, the inner cutter sleeve and the transmission screw 211 are circumferentially rotationally connected and axially fixedly connected through the insertion of the circumferentially arranged annular limiting clamping piece into the annular limiting clamping groove.

[0099] In a specific implementation, the outer side of the inner cutter sleeve is circumferentially provided with an annular limiting clamping groove, and the inner side of the transmission screw 211 is circumferentially provided with an annular limiting clamping piece matched with the annular limiting clamping groove. The circumferential rotating connection between the transmission screw 211 and the inner cutter sleeve is achieved by inserting the annular limiting clamping piece into the annular limiting clamping groove. The axial fixed connection is achieved, that is, the inner cutter sleeve and the transmission screw 211 can rotate relative to each other, but cannot have relative displacement in the axial direction. Of course, the inner side of the transmission screw can be circumferentially provided with an annular limiting clamping groove, and the outer side of the inner cutter sleeve can be circumferentially provided with an annular limiting clamping piece matched with the annular limiting clamping groove. This embodiment does not make specific limitations.

[0100] An inner wall of the proximal end shell 204 is axially provided with a guide rail, and the transmission screw 211 is slidingly arranged on the guide rail. By driving the screw sleeve 210 to rotate, the transmission screw 211 moves along the guide rail, so as to limit the axial movement distance of the transmission screw 211.

[0101] As an embodiment, the proximal end handheld part 2 further comprises an endoscope fixing piece 201 and a distal end shell 203. The endoscope fixing piece 201 comprises a sheath seat 2011 and a sheath seat locking piece 2012. The sheath seat 2011 is movably sleeved on the outer sheath tube 101, so that the sheath seat 2011 can move axially on the outer sheath tube 101.

[0102] The sheath seat 2011 is provided with a second luer joint matched with a first luer joint on an endoscope. The sheath seat 2011 is assembled and connected with the second luer joint through the first luer joint, so as to realize the fixed connection with the endoscope.

[0103] This embodiment does not limit the specific connection form of the first luer joint and the second luer joint. It can be a threaded connection, a clamping connection or other detachable fixed connection mode.

[0104] The distal end shell 203 is a sleeve type structure with open ends. The distal end shell 203 is fixedly sleeved on the proximal end of the outer sheath tube 101. The distal end shell 203 is located between the sheath seat 2011 and the proximal end shell 204. The sheath seat 2011 is axially slidingly connected with the distal end of the distal end shell 203 and can be locked with the distal end shell 203 through the sheath seat locking piece 2012. The proximal end of the distal end shell 203 is axially slidingly connected with the distal end of the proximal end shell 204.

[0105] The fixed connection with the endoscope is achieved by assembling and connecting the first luer joint on the endoscope with the second luer joint on the sheath seat 2011. After the sheath seat 2011 is fixed with the endoscope, the relative position of the outer sheath tube 101 and the endoscope is adjusted by adjusting the relative position of the sheath seat 2011 and the distal end shell 203, and after the adjustment is completed, the sheath seat locking piece 2012 and the distal end shell 203 are locked, thereby realizing the fixation of the outer sheath tube 101 and the endoscope.

[0106] Since the technical scheme of adjusting and locking between the two structures (the sheath seat 2011 and the distal end shell 203) by the locking piece (the sheath seat locking piece 2012) belongs to a relatively mature technology in the mechanical field, the present application does not make specific limitations thereon, for example, the sheath seat locking piece 2012 can be a lock cap structure, the lock cap structure is internally provided with an internal thread, the sheath seat 2011 is provided with an external thread matched with the internal thread, and the sheath seat 2011 is locked on the distal end shell 203 by the assembly of the internal thread and the external thread. When the lock cap structure is loosened, the sheath seat 2011 and the distal end shell 203 are in an unlocked state and can be axially slid. Of course, the sheath seat locking piece 2012 of the present application is not limited to the lock cap structure, but can also be a threaded fastener. Specifically, one side wall of the sheath seat 2011 is provided with a threaded hole, the sheath seat locking piece 2012 is a threaded fastener matched with the threaded hole, the first end of the threaded fastener passes through the threaded hole into the sheath seat 2011, and the second end is located outside the sheath seat 2011. The threaded fastener is tightened by manually rotating the second end of the threaded fastener, so that the first end of the threaded fastener abuts against the distal end shell 203, thereby fixing the proximal end shell 204 and the sheath seat 2011. The threaded fastener can be a locking screw or the like.

[0107] The conventional biopsy needle is usually fixed with the endoscope through the proximal end shell and the endoscope, and is uniformly operated by the endoscope operator. However, the rotary cutting biopsy needle has a motor, and the motor handle and the proximal end shell are assembled together and have a large weight. If the conventional fixation mode is adopted, the fixation of the proximal end shell and the endoscope will greatly increase the difficulty of the endoscope operation and the operation difficulty of the endoscope operator. The endoscope is fixed on the outer sheath tube by the endoscope fixing piece on the outer sheath tube in the present application, the proximal end shell and the motor handle are held and operated by another special operator. Therefore, the holding and operation of the endoscope and the holding and operation of the proximal end shell are separated, the operation difficulty is reduced, and the adjustment range of the intervention depth of the outer sheath tube is increased.

[0108] The proximal handheld portion 2 also includes a puncture depth adjustment device 202, which includes an adjustment sleeve 2021 and a sleeve locking member 2022. The adjustment sleeve 2021 is movably mounted on the distal housing 203. During use, the puncture depth is first set by adjusting the position of the adjustment sleeve 2021 on the distal housing 203; the adjustment sleeve 2021 is then locked to the distal housing 203 using the sleeve locking member 2022; and finally, the proximal housing 204 is slid distally to achieve puncture. The puncture is completed when the distal end of the proximal housing 204 contacts the adjustment sleeve 2021, that is, the adjustment sleeve 2021 blocks the proximal housing 204 from sliding further distally.

[0109] Since the technical solution of adjusting and locking the two structures (adjusting sleeve 2021 and the inlet housing) by using a locking member (sleeve locking member 2022) is a relatively mature technology in the mechanical field, the present invention does not impose any specific restrictions on this. For example, the sleeve locking member 2022 can be a locking cap structure with an internal thread, and the adjusting sleeve 2021 has an external thread that adapts to the internal thread. The internal and external threads are assembled to lock the adjusting sleeve 2021 to the distal housing 203. When the locking cap structure is loosened, the adjusting sleeve 2021 and the distal housing 203 are in an unlocked state, allowing axial sliding operation. Of course, the sleeve locking member 2022 of the present invention is not limited to a lock cap structure, and can also be a threaded fastener. Specifically, a threaded hole is provided on one side wall of the adjustment sleeve 2021, and the sleeve locking member 2022 is a threaded fastener adapted to the threaded hole. The first end of the threaded fastener passes through the threaded hole and enters the adjustment sleeve 2021, and the second end is located outside the adjustment sleeve 2021. The threaded fastener is tightened by manually tightening the second end of the threaded fastener so that the first end of the threaded fastener abuts against the distal housing 203, thereby fixing the proximal housing 204 to the adjustment sleeve 2021. The threaded fastener can be a locking screw or other structure.

[0110] Example 2

[0111] This embodiment provides a microscopic positive negative pressure suction biopsy system, comprising the negative pressure suction rotary biopsy needle and the negative pressure device described in Example 1, wherein the negative pressure device performs negative pressure suction on the tissue in the rotary cutting blade tube 102 through the negative pressure interface 2041 .

[0112] As an embodiment, the biopsy system further includes a syringe. After sampling is completed, the syringe injects physiological saline into the rotary cutter tube 102 through the negative pressure interface 2041 to flush out the tissue sample in the rotary cutter tube 102 .

[0113] The negative pressure device and the injector can share one interface or use separate interfaces, and are connected with the negative pressure interface 2041.

[0114] As an embodiment, the negative pressure interface 2041 is further connected with a three-way joint, which comprises a first interface, a second interface and a third interface, the first interface is used for communication with the negative pressure interface 2041, the second interface is used for connecting the negative pressure device, and the third interface is used for connecting the injector, and the three-way joint is provided with an adjusting switch, and the first interface realizes switching of the passageway with the second interface and the third interface through the adjusting switch. For example, when the adjusting switch is in gear I, the negative pressure suction of the negative pressure device can be transmitted to the distal end of the rotary cutter tube 102 to realize adsorption of the tissue; when the adjusting switch is in gear II, the injector can flush out the tissue in the rotary cutter tube 102 for sampling to ensure the integrity of the tissue.

[0115] The specific type of the negative pressure device is not limited in the embodiment, and can be a negative pressure suction needle cylinder or a negative pressure pump. The following takes the negative pressure device as a negative pressure pump to illustrate the adjusting method of the negative pressure size.

[0116] In order to realize the adjustment of the negative pressure size, the biopsy system further comprises a host computer, and the host computer comprises a master control module, the master control module is electrically connected with the negative pressure pump through a negative pressure driving module, the master control module controls output of a DAC analog signal, and outputs an adjustable pressure driving signal. Since the driving voltage of the negative pressure pump is in linear relationship with the flow, the driving voltage of the negative pressure pump is controlled, and the flow size of the negative pressure pump can realize the adjustment of the negative pressure size.

[0117] The host computer further has a negative pressure sensor, which monitors the real-time negative pressure size of the negative pressure pump, and feeds back the accurate negative pressure value to the master control module. Based on the feedback negative pressure value, the master control module adjusts the negative pressure value by adjusting the flow size of the negative pressure pump.

[0118] The master control module is further electrically connected with a rotary cutting driving motor and a stroke driving motor through a motor driving module. During sampling, the negative pressure is adjusted in three stages:

[0119] (1) In the initial stage, the negative pressure value is small, <10KPa, so that the annular blade of the rotary cutter tube 102 can be close to the tissue, and the annular blade of the rotary cutter tube 102 can cut and separate the tissue.

[0120] (2) Sampling stage, gradually increase the negative pressure value based on the rotation depth of the rotary cutter tube 102. For example, when rotating in 1mm, increase 1KPa negative pressure value. When rotating in 20mm, increase the negative pressure value to 30KPa. If the host finds that the rotation drive motor torque is significantly smaller (identified by motor current), it means that the cavity tissue in the rotary cutter tube 102 is blocked and cannot be deepened, causing the annular cutter of the rotary cutter tube 102 to fail to cut and separate the tissue. At this time, the negative pressure pump increases the negative pressure value, and the tissue in the cavity of the rotary cutter tube 102 moves to the deep cavity, so that there is space to accommodate more tissue at the distal end of the rotary cutter tube 102, thereby improving the sampling amount.

[0121] (3) Sampling end breakage stage, after sampling, the negative pressure pump provides a larger negative pressure value, such as > 30KPa, so that the suction force and friction force are superimposed to completely separate the sample tissue.

[0122] (4) Sample collection stage, turn off the negative pressure, adjust the three-way joint, inject normal saline in the cavity of the rotary cutter tube 102, and flush out the sample tissue.

[0123] Although the present application is disclosed as above, the present application is not limited thereto. Any person skilled in the art can make various changes and modifications without departing from the spirit and scope of the present application, and therefore the protection scope of the present application should be subject to the scope defined by the claims.

Claims

1. A positive negative pressure suction biopsy needle under a microscope, characterized in that: The device comprises a distal conduit portion and a proximal handheld portion, wherein the distal conduit portion comprises an outer sheath, a rotary cutter tube, and a puncture needle that are movably sleeved in sequence from the outside to the inside; the proximal handheld portion comprises a proximal housing and a rotary cutter tube transmission assembly, and the proximal end of the rotary cutter tube is installed in the proximal housing through the rotary cutter tube transmission assembly; A negative pressure interface is provided on the proximal end wall of the proximal housing, and the negative pressure interface is used to connect to a negative pressure device; The rotary cutter tube transmission assembly includes a circumferential rotation transmission mechanism and an axial movement transmission mechanism, the circumferential rotation transmission mechanism includes a core shaft assembly and a rotating shaft sleeve located in the proximal end housing, the core shaft assembly is fixedly sleeved on the rotary cutter tube, the rotating shaft sleeve is sleeved on the core shaft assembly, and is slidably connected to the core shaft assembly in the axial direction and relatively fixedly connected in the circumferential direction; the rotating shaft sleeve and the rotary cutter tube are dynamically sealed by a first dynamic seal; the proximal end of the rotating shaft sleeve is fixedly sealed and connected to a rotary tube, and the rotary tube is also dynamically sealed and connected to the negative pressure interface through a second dynamic seal; the rotating shaft sleeve is driven to rotate, so that the rotating shaft sleeve drives the core shaft assembly to rotate, and then drives the rotary cutter tube to rotate; The axial movement transmission mechanism includes a screw sleeve and a transmission screw, the screw sleeve is rotatably arranged in the proximal housing and is threadably engaged with the transmission screw for transmission; the transmission screw sleeve is mounted on the rotating sleeve and is relatively fixed to the core shaft assembly in the axial direction and is rotatably connected to the core shaft assembly in the circumferential direction; the screw sleeve is driven to rotate so that the rotational motion of the screw sleeve is converted into axial movement of the transmission screw, and then the transmission screw drives the core shaft assembly and the rotary cutter tube to move axially; The rotary cutting knife tube includes a distal metal tube, a metal wire spring tube, a proximal metal tube and a polymer sealing tube. The distal end of the distal metal tube is an annular blade, and the proximal end face of the distal metal tube is fixedly connected to the distal end face of the metal wire spring tube; the polymer sealing tube is at least sealed on the metal wire spring tube and at the connection between the metal wire spring tube and the distal metal tube; the proximal metal tube is fixedly sleeved on the proximal end of the polymer sealing tube.

2. The biopsy needle according to claim 1, characterized in that The rotating shaft sleeve is fixedly connected to a rotating gear, and the rotating shaft sleeve drives the rotating gear to perform a rotating motion through a rotating driving motor.

3. The biopsy needle according to claim 2, characterized in that The screw sleeve is fixedly connected to the travel gear, and the screw sleeve drives the travel gear to rotate through the travel drive motor.

4. The biopsy needle according to claim 3, characterized in that The proximal handheld portion further comprises a motor handle, in which both the rotation drive motor and the stroke drive motor are mounted, and the motor handle is fixedly connected to the proximal housing.

5. The biopsy needle according to claim 1, characterized in that The core shaft assembly includes a fixed tube and an inner knife sleeve, the fixed tube is fixedly outer-circuited on the rotary cutter tube, the inner knife sleeve is fixedly outer-circuited on the fixed tube, the rotating sleeve is outer-circuited on the inner knife sleeve, and the rotating sleeve and the inner knife sleeve are connected in an axial sliding manner by inserting an axial protrusion into an axial guide groove, and are fixedly connected in the circumferential direction; The inner cutter sleeve and the transmission screw are connected in a circumferential rotation direction and fixedly connected in an axial direction by inserting an annular limiting clamping piece provided circumferentially into an annular limiting clamping groove.

6. The biopsy needle according to claim 1, characterized in that A guide rail is further provided on the inner wall of the proximal shell, and the transmission screw is slidably arranged on the guide rail.

7. The biopsy needle according to claim 1, characterized in that The proximal handheld portion further includes an endoscope fixing member and a distal housing. The endoscope fixing member includes a sheath seat and a sheath seat locking member. The sheath seat is movably sleeved on the outer sheath tube. The sheath seat is provided with a second Luer connector that is adapted to the first Luer connector on the endoscope. The sheath seat is assembled and connected to the second Luer connector via the first Luer connector to achieve a fixed connection with the endoscope. The distal shell fixing sleeve is at the proximal end of the outer sheath tube, the sheath seat is axially slidingly connected to the distal end of the distal shell, and can be locked with the distal shell by the sheath seat locking piece; the proximal end of the distal shell is axially slidingly connected to the distal end of the proximal shell.

8. The biopsy needle according to claim 7, characterized in that The proximal handheld part also includes a puncture depth adjustment device, which includes an adjusting sleeve and a sleeve locking piece. The adjusting sleeve is movably mounted on the distal shell. When in use, the puncture depth is first set by adjusting the position of the adjusting sleeve on the distal shell; then the adjusting sleeve is locked on the distal shell by the sleeve locking piece; finally, the proximal shell is slid toward the distal end to achieve puncture.

9. The negative pressure suction biopsy needle according to claim 8, characterized in that: The distal end housing is provided with a puncture depth scale.

10. The biopsy needle according to claim 1, characterized in that The inner ring of the rotating sleeve is provided with a first groove, and the first dynamic seal is fixedly installed in the first groove.

11. The biopsy needle according to claim 1, characterized in that A second groove is provided on the inner side of the proximal end wall of the proximal housing. The second groove is communicated with the negative pressure interface, and the second dynamic seal is fixedly installed in the second groove.

12. The biopsy needle according to claim 1, wherein The first dynamic seal and / or the second dynamic seal are sealing rings.

13. The biopsy needle according to claim 12, characterized in that The sealing ring is a varnish seal or a silicone seal ring.

14. A positive negative pressure suction biopsy system under a microscope, characterized in that: It comprises the biopsy needle according to any one of claims 1 to 13 and a negative pressure device, wherein the negative pressure device performs negative pressure suction on the tissue in the rotary cutter tube through the negative pressure interface.

15. The biopsy system according to claim 14, wherein: It also includes a syringe. After the sampling is completed, the syringe injects physiological saline into the rotary cutter tube through the negative pressure interface to flush out the tissue sample in the rotary cutter tube.

16. The biopsy system according to claim 14, wherein: It also includes a host, which includes a main control module. The main control module is electrically connected to the negative pressure device through a negative pressure driving module to control the negative pressure of the negative pressure device.

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